D012039NCT04553484

Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods.

An observational study of D012039 and D001775, run by Semler Scientific at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Measuring Cardiovascular Performance Using Common Methods in subjects. Read more about this study

Who is it for?: Ages 45 years and older
Conditions the study is for: D012039, D001775
How many people: 657 participants
Where: 4 sitesUnited States
Study dates: 5 Aug 2020to 14 Jan 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 45 Years and older Female and Male

Who may be able to join

At least 50 Patients from New York Heart Association (NYHA) Class 1 (One or more AHA Risk Factors, asymptomatic), ≤75% (36) Male, ≥25% (12) Female
At least 50 Patients from NYHA Class 2 (symptomatic), ≤75% (36) Male, ≥25% (12) Female

Who cannot join

Subjects on mechanical ventilation.
Subjects who require decisions by a medical power of attorney.
Subjects unable to safely perform forced expiration.
Subjects with known technically difficult (TDS) trans-thoracic echocardiographic windows.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

JF Southwest Heart Clinic, P.A.
Houston, Texas, 77072
Southwest Clinical Trials
Houston, Texas, 77081
Integrated Cardiology Group, LLC, d/b/a Bryan Heart
Lincoln, Nebraska, 68506
Middle Georgia Heart and Vascular Center
Macon, Georgia, 31210

Other trials in United States

About this study

Measuring Cardiovascular Performance Using Common Methods in subjects.

Read the detailed description

This study will conduct measurements of cardiovascular performance by echocardiography (Echo), Brain Natriuretic Peptide (BNP) blood serum levels and blood flow by volume plethysmography (VP) in subjects who meet the AHA/ACC criteria for screening for peripheral arterial disease (PAD).

Conditions: D012039, D001775
Being tested: No intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionDiagnostic test
No intervention

Study groups in NCT04553484
Study group	Role	What they receive
All subjects enrolled		The feasibility of conducting all three tests, echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), on all subjects met the enrollment criteria. Receives: Diagnostic Test: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Performing Echo, BNP, and VP on Human Subjects.
The feasibility of performing three common tests, Echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), in the same subject was assessed. Each of the 657 participants were submitted to a brief non-invasive blood flow and cardiac performance test (plethysmography (VP) and Echocardiography (Echo)). Each of the 236 participants were subject to blood drawn test, Brain Natriuretic Peptide (BNP).
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 202014 Jan 2022

First posted17 Sep 2020
Study start5 Aug 2020
Primary completion29 Dec 2021
Study completion14 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for D012039Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 657 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04553484
Sponsor's protocol ID: 35-0102
Status last verified: Jun 2024
First submitted: 4 Sep 2020
Last updated: 3 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measuring Cardiovascular Performance and Blood Flow Using Common But Never Compared Methods.
ClinicalTrials.gov ID: NCT04553484
Acronym / sponsor ID: 35-0102
Conditions: D012039, D001775
Study type: Observational
Recruitment status: Completed
Enrolment: 657 participants (actual)
Lead sponsor: Semler ScientificIndustry (pharma, biotech, devices)
Study start: 5 Aug 2020 (actual)
Primary completion: 29 Dec 2021 (actual)
Study completion: 14 Jan 2022 (actual)
First posted: 17 Sep 2020 (actual)
Results: Posted 3 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Measuring Cardiovascular Performance Using Common Methods in subjects.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All subjects enrolled	–	Diagnostic Test: No interventionThe feasibility of conducting all three tests, echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), on all subjects met the enrollment criteria.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 45 Years and older Female and Male

Key inclusion criteria (2 listed)

At least 50 Patients from New York Heart Association (NYHA) Class 1 (One or more AHA Risk Factors, asymptomatic), ≤75% (36) Male, ≥25% (12) Female
At least 50 Patients from NYHA Class 2 (symptomatic), ≤75% (36) Male, ≥25% (12) Female

Key exclusion criteria (4 listed)

Subjects on mechanical ventilation.
Subjects who require decisions by a medical power of attorney.
Subjects unable to safely perform forced expiration.
Subjects with known technically difficult (TDS) trans-thoracic echocardiographic windows.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionNo intervention	Diagnostic test	All subjects enrolled

Primary outcome

Feasibility of Performing Echo, BNP, and VP on Human Subjects.
Time frame: Baseline
The feasibility of performing three common tests, Echocardiography (Echo), Brain Natriuretic Peptide (BNP) and volume plethysmography (VP), in the same subject was assessed. Each of the 657 participants were submitted to a brief non-invasive blood flow and cardiac performance test (plethysmography (VP) and Echocardiography (Echo)). Each of the 236 participants were subject to blood drawn test, Brain Natriuretic Peptide (BNP).

Results and safety

Results posted to the registry on 3 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects Enrolled.	657	657

Primary outcome: Feasibility of Performing Echo, BNP, and VP on Human Subjects.

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Echo, Volume Plethysmography n = 657	Brain Natriuretic Peptide (BNP) n = 236
Value	657	236

Population analysed: All subjects could safely do the Echo and VP tests, and after the protocol was amended, 100% of subjects could safely do the BNP as well. The quality of the test results was not assessed in this study.

Adverse events

Time frame: Baseline. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Measuring Cardiovascular Performance and Blood Flow.	0 of 657 (0%)	0 of 657 (0%)	0 of 657

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jim Kermode study director

Semler Scientific

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of D012039 and D001775, run by Semler Scientific at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Performing Echo, BNP, and VP on Human Subjects. (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04553484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.